“Put Down that Camera,” No MoreJuly 18, 2013
By Doug Farquhar –
For decades (although not quite since the invention of film), the debate has raged among lawyers who advise clients about FDA inspections: can regulated industry insist that FDA investigators conducting inspections without a warrant put away their cameras, when the investigators try to take photographs in a facility? FDA issued a draft Guidance last week, titled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection,” that explicitly gives investigators the right to take pictures, although FDA may be stretching its inspectional authority beyond what is required under the relevant statute.
Let’s start with the statute. Section 704 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) (21 U.S.C. §374(a)(1)(B)) has required, for years, FDA-regulated industry to allow FDA “officers or employees” to “inspect, at reasonable times and within reasonable limits and in a reasonable manner,” any facility and “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.” FDA has always claimed that this gives them the authority to take photographs while conducting an inspection. Its Investigations Operations Manual states, in Section 188.8.131.52, that, if “management objects to taking photographs, explain that photos are an integral part of an inspection and present an accurate picture of plant conditions.” The Manual then advises inspectors, if plant management continues to refuse, to cite two cases that the Manual claims authorize the taking of photographs, but those cases, in the view of critics like me, actually only authorize use of photographs in court when the investigated entity has not refused to permit photographs to be taken. Finally, says the Manual, inspectors should obtain the names of the lawyers representing the company and call the management in their district office if an establishment still refuses to permit photographs.
To avoid any ambiguity, when FDA seeks an administrative warrant for an inspection, it usually authorizes itself to take photographs, and when Consent Decrees are signed by companies, the Decrees universally require that the companies allow FDA inspectors to take photographs. But, as far as we know, there has never been a case in which a court has held that a company illegally refused or limited an inspection by prohibiting FDA investigators to take photographs.
Then along came the FDA Safety and Innovation Act (“FDASIA”) (our firm’s summary of the law, which was enacted in 2012, is available here). FDASIA authorized FDA, in Section 707(b), to issue a guidance about what constitutes refusing an authorized FDA inspection, which is a crime under Section 301(f) (21 U.S.C. §331(f)).
We were waiting for this shoe to drop, and, sure enough, the Guidance issued last week states (Section V.B):
Photographs are an integral part of an FDA inspection because they present an accurate picture of facility conditions.
Doesn’t that sound familiar? The draft Guidance then continues:
Not allowing photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator(s) to be necessary to effectively conduct that particular inspection. Examples of conditions or practices effectively documented by photographs include, but are not limited to: evidence of rodents or insect infestation; faulty construction or maintenance of equipment or facilities; product storage conditions; product labels and labeling; and visible contamination of raw materials or finished products.
Is this an unlawful extension of FDA’s inspection powers? It would be interesting to see what would happen with a test case for a company that refused to permit photography.
And why does this matter? One veteran lawyer once told me that, when he was at FDA, they had four “dirty warehouse” cases they could pursue, but resources only allowed FDA to take two of them. They took the two where they had photographs.
The draft Guidance on Inspections, which is not binding law, even after it becomes final, does some other things, too. In general terms, the Guidance defines the various types of actions, inaction, and circumstances that the FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of FDCA § 501(j). FDASIA amended the statute to add this new section, which deems a drug to be adulterated if “it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.”